Clinical study to assess effectiveness of Zipitrit skin cream in the management of skin fungal infection and eczema.

Phase 2

• Conditions: Health Condition 1: L20-L30- Dermatitis and eczema

• Registration Number: CTRI/2024/03/064225
• Lead Sponsor: M. N. Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Age group between 18 to 65 years old, both inclusive

2. Confirmed diagnosis of skin fungal infection

3. No systemic antifungal treatment within the previous two weeks

4. No use of topical antifungal agents within the previous seven days

5. No history of allergy to components of the study medication

6. Subjects ready to take injection TT before application of study drug

Inclusion criteria for eczema:

1. Patients of either sex in the age group between 18 to 65 years both inclusive;

2. IGA score of 2 or 3 (mild or moderate) during screening and baseline;

3. BSA of AD involvement of 4-12%;

4. EASI of 5-20 Clinical diagnoses of Atopic Dermatitis (as defined by Hanifin and Rajka criteria);

5. Atopic Dermatitis should be present for at least three months with stable disease for more than or equal to 1 month prior to screening.

6. Subjects ready to take injection TT before application of study drug

Exclusion Criteria

1. Pregnant or lactating women or women of child bearing positive urine pregnancy test at screening. All subjects agree to use an adequate contraceptive method throughout the study;

2. Use of biologic therapy within 12 weeks;

3. Regular use of tanning booth within 4 weeks;

4. Concomitant dermatologic (e.g. irritant contact dermatitis, allergic contact dermatitis, psoriasis, etc.) or other medical condition(s) which may interfere with study assessments;

5. Any other comorbid condition which is not on stable prescription for last 3 months.

6. Subjects who are using any concomitant medications that in the investigators opinion, could affect the subjects atopic dermatitis (e.g. Antihistamines) Subjects using such medications and have been stable on treatment for at least one month prior to visit 2 (Day 1 of IP) and no changes to these medications are planned during study may be included in the study at the investigators discretion;

7. Abnormal renal function (defined as serum creatinine more than 1.5xULN) or abnormal liver function (defined as any transaminases more than 2xULN);

8. Known hypersensitivity to any of the components of the study drug;

9. Known or suspected history of alcohol or drug abuse;

10. Subjects with a history of human immunodeficiency virus (HIV) as determined by medical history;

11. Subjects who are receiving any investigational drug or who participated in a similar clinical trial with an investigational product within the last 3 months;

12. Any other condition as per discretion of investigator would interfere with the clinical evaluations.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To treat skin fungal infections and assess the time required (in days) for complete healing and symptom resolution. <br/ ><br>2.Eczema Area and Severity Index (EASI) <br/ ><br>EASI assesses the extent and severity of atopic dermatitis. EASI is a composite index with scores ranging from 0 to 72. Higher values indicate more severe or extensive disease. <br/ ><br>Timepoint: From baseline to Day 28